1. Field of the Invention
The present invention relates to medical and surgical protective devices and shields, and particularly to an IV protector which encloses an IV catheter attached to IV tubing in a protective sheath to avoid contamination and the risk of spreading infection encountered from the spattering of blood which normally occurs when removing and disposing of the catheter and the tubing.
2. Description of the Related Art
Intravenous (IV) therapy is a versatile technique used for the administration of fluids. It has been used for such purposes as the maintenance of fluid and electrolyte balance, the transfusion of blood, administration of nutritional supplements, chemotherapy, and the administration of drugs and medications. Fluids may be administered intravenously by injection through a hypodermic syringe, or intermittently or continuously by infusion using a needle or a plastic or silicon catheter.
Although there are many advantages to be derived from the intravenous administration of fluids, the past two decades have brought heightened awareness of the risks of propagating infectious diseases associated with the technique, particularly due to the HIV virus. One consequence of this heightened awareness has been the development of various devices to reduce the risk of spreading infectious diseases. Probably the majority of devices which have been developed are concerned with the danger of accidental puncture wounds occurring through use of the hypodermic syringe needle or to the particular needle or trocar used to introduce a continuous infusion IV catheter.
Continuous infusion IV therapy may be generally divided between peripheral IV therapy and central venous IV therapy, depending on the site of administration. Catheters used for peripheral IV therapy tend to be short, between 3/4" and 1 1/4" long, or occasionally 2" long for insertion into a deep vein. Catheters for central venous IV therapy tend to be much longer, and are outside the scope of the present invention.
A peripheral IV catheter is made of soft, flexible plastic or silicon, generally between 16 gauge and 24 gauge. In a procedure known as venipuncture the catheter is inserted into a vein in the patient's hand, foot, or the inner aspect of the arm or any vein in the body that will accept an IV catheter. When inserting a peripheral IV catheter, an IV infusion set is prepared, filling the IV tubing with fluid and eliminating any air, closing the fluid clamp. A tourniquet is applied proximal to the venipuncture site, and a variety of techniques are used to dilate the vein. Wearing disposable gloves, the venipuncture site is cleansed and a the vein is retracted or anchored by placing a thumb over the vein about two to three inches distal to the site. A catheter with a stylet advanced through its lumen so that the pointed tip extends beyond the cannula of the catheter or a butterfly needle is introduced into the vein by inserting the bevel into the vein at about a 20.degree. to 30.degree. angle with the bevel facing up in order to pierce one wall of the vein. Blood return in the tubing of the butterfly needle or the flashback chamber of the over the needle catheter indicates that the vein has been entered, and the needle is lowered towards the skin and the catheter is advanced about 1/4" into the vein. The stylet is loosened and the catheter is gently advanced farther up into the vein until the hub of the catheter is against the venipuncture site. The tourniquet is loosened and the needle or stylet is removed from the catheter. The needle adaptor of the infusion tubing is secured to the hub of the catheter, and the roller clamp is opened. The flow rate may be controlled either by adjusting the roller clamp or an infusion pump, and the catheter is secured to the venipuncture site by gauze and adhesive tape.
The protective devices developed to prevent accidental needle puncture generally are designed to apply to the part of the IV infusion process. Needle shields or sheathes have been developed which are slidable, e.g., U.S. Pat. No. 5,011,475, issued Apr. 30, 1991 to Richard A. Olson (sheath slidable in slots defined in barrel of syringe); pivotal, e.g., U.S. Pat. No. 5,603,699, issued Feb. 18, 1997 to Jerry P. Shine (shield pivotally attached at base of syringe and pivotally operated by lever connected to gear mechanism); and frangible, e.g., U.S. Pat. No. 5,344,404, issued Sep. 6, 1994 to Carl L. Benson (shield in different segments secured by frangible means such as plastic shrink wrap). Some of the shields and sheathes are open over the tip of the needle, such as U.S. Pat. No. 5,267,972, issued Dec. 7, 1993 to Wayne W. Anderson (sheath spring biased to normally enclose needle, retracts around barrel of syringe when pressed against patient' skin), while others lock over and enclose the tip of the needle after use, such as U.S. Pat. No. 5,366,447, issued Nov. 22, 1994 to Carol A. Gurley (Sleeve sliding over barrel of hypodermic syringe, the sleeve having a seal at the end to seal the sleeve over the needle when fully extended) and U.S. Pat. No. 5,685,860, issued Nov. 11, 1997 to Chang, et al. (needle with a cap attached by a sleeve to the needle hub, capping needle tip after the needle is removed from the catheter hub).
Another type of protective device is disclosed in U.S. Pat. No. 5,343,875, issued Sep. 6, 1994 (clamp with troughs for the fingers to grasp an IV catheter having an injection port to protect the fingers from accidental puncture when inserting a needle through the cap). Still other devices are designed to protect against accidental dislodgement or damage to the tubing while the catheter is connected to the venipuncture site. Examples of such devices include U.S. Pat. No. 5,112,313, issued May 12, 1992 to Patricia L. Sallee (a plastic housing with an opening for the IV tubing using split grommets, the housing taped over the patient's skin over an indwelling needle) and U.S. Pat. No. 5,116,324, issued May 26, 1992 to Brierly, et al. (a base with a hinged cover, the base having tabs taped to the patient's skin and a bridge for insertion of the IV tubing between the base and the skin).
The present invention is directed towards a different problem involving the risk of spreading infection which occurs during the process of removal and disposal of a soft, flexible, indwelling peripheral IV catheter. When the IV infusion is no longer needed, the tape and dressing are removed from the venipuncture site. The IV tubing is clamped, generally by moving a roller clamp disposed between the drip chamber and the tubing to the off position. Wearing disposable gloves, the medical personnel applies a gauze sponge or alcohol pad to the venipuncture site with one hand, while grasping the hub of the catheter and withdrawing it from the venipuncture site by pulling straight back with the other hand. The medical personnel applies pressure to the venipuncture site for one to two minutes to prevent the formation of hematoma. A new dressing is taped to the venipuncture site. The used intravenous tubing with the catheter still in place is disposed of with the other sharps.
The problem which often occurs during this process is that even though the IV tubing is clamped, there is still blood and other fluids (often transparent, such as plasma, IV fluids, lymph fluids, etc.) backed up in the lumen and hub of the catheter and within the IV tubing. Very rarely is the sharps disposal container placed adjacent to the patient, and since the medical personnel often requires both hands to apply pressure to the venipuncture site as well as dressings and tape, the catheter must be released and has a tendency to spatter the fluids retained in the catheter and the end of the tubing over the patient, bed, clothing, and the floor. On a few occasions, there may be a spurt of fluid as the catheter exits the patient's skin.
Although the only wound site open at the time may be the venipuncture site, nevertheless, the fluids released from the end of the cannula may be absorbed by clothing, bed linens, floor coverings, and the like,and persist for quite some time. Since the time of Pasteur, it has been well known that microorganisms persisting in fluids are pathogenic carriers of infectious diseases. One of the more intractable and refractory challenges facing the medical profession is the persistence of nocosomial infections. Hence, it is desirable to prevent the indiscriminate splattering of blood and other fluids from the tip of the catheter upon its removal from the venipuncture site. Among other diseases which may be spread by such fluids are HIV, hepatitis, gram-positive bacteremia, staphylococcal bacteremia, and numerous other bacterial diseases.
An example of a device which partially addresses this problem is disclosed in U.S. Pat. No. 4,943,284, issued Jul. 24, 1990 to Frederick L. Ehrlich. The Ehrlich patent shows what is essentially a plastic baggie rolled up and glued around the circumference of the catheter substantially near the hub of the catheter. When the catheter is removed, the baggie is unrolled to cover the tip of the catheter and sealed with a wire tie, rubber band, adhesive, etc. There may be two such baggies, unrolling in opposite directions to cover the entire device.
There are, however, problems with the Ehrlich device. The Ehrlich device commonly requires two hands to unroll the plastic baggie, while medical personnel commonly need at least one hand available to maintain pressure on the venipuncture site and apply a dressing. It is cumbersome to use and hard to manipulate while wearing disposable gloves, particularly given the narrow diameter of the catheter hub and cannula. The plastic is prone to rupture and tear while unrolling and after sealing around the tip of the catheter. The Gurley and Chang devices are specifically adapted for use with a hypodermic syringe, in the one case depending in slots in the outside of the barrel for attaching and sliding the sheath, and in the other on a needle hub to which the cap is connected by a sleeve.
None of the above inventions and patents, taken either singularly or in combination, is seen to describe the instant invention as claimed. Thus an IV protector solving the aforementioned problems is desired.